EMA Updates Guidance on Post-Approval Change Management…
On 11 December 2025, the European Medicines Agency (EMA) published revised guidance on Post-Approval Change Management Protocols (PACMPs), u…
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EU Announces Landmark Reform of Pharmaceutical Legislat…
On 11 December 2025, the European Commission announced a political agreement on a major reform of EU pharmaceutical legislation, marking the…
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US FDA Announces Deployment of Agentic AI Capabilities …
On December 1, 2025, the U.S. Food and Drug Administration (FDA) announced the deployment of new agentic AI capabilities to enhance pre-mark…
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EU Council Approves Postponement of Chemical Packaging …
On 17 November 2025, the Council of the European Union approved a regulation postponing several upcoming compliance deadlines under the revi…
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Global Regulators Confirm No Link Between Paracetamol U…
Between September 23–26, 2025, multiple health authorities, including Singapore’s Health Sciences Authority (HSA), Australia’s Therape…
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Regulatory Update on ISO Targets 1,4-Dioxane in Cosmeti…
On 7 August 2025, the International Organization for Standardization (ISO) announced the registration of a new project, ISO/AWI 24913, d…
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Indonesia BPOM Revises Drug Registration Rules to Strea…
Published on August 19, 2025, by the Indonesian National Agency of Drug and Food Control (BPOM), Regulation No. 23 of 2025 introduces major…
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$7 Billion Parkinson’s Disease Market by 2033: Implic…
On August 5, 2025, Clinical Trials Arena released a market forecast detailing significant growth in Parkinson’s disease (PD) therapeutics …
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FDA Launches Regulatory Accelerator to Boost Medical De…
FAQs What is the FDA’s Regulatory Accelerator? The Regulatory Accelerator is an initiative launched by the FDA on 24 July 2025 to suppor…
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Drug Shortages Threaten Patient Safety in Africa
The U.S. Agency for International Development (USAID) is responsible for nearly 70% of American global health aid [9]. As a result, recent p…
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